Pulsecare Medical Announces NMPA Approval of NxPFA™, the World's First Nanosecond PFA System, Ushering in the PFA 3.0 Era

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• USA - English

SHENZHEN, China, Aug. 4, 2025 /PRNewswire/ -- Pulsecare Medical, a pioneer in cardiovascular intervention technologies, announced that its innovative NxPFA™ nanosecond pulsed field ablation (ns-PFA) systemhas received marketing approval from China's National Medical Products Administration (NMPA). As the world's first third-generation ns-PFA system utilizing high-voltage nanosecond pulses for pulmonary vein isolation (PVI) in atrial fibrillation (AF) treatment, this breakthrough marks the dawn of the PFA 3.0 era and represents the innovative capabilities of Pulsecare Medical in cardiovascular multimodal therapy.

The World's First Commercially Approved Nanosecond PFA

PFA has revolutionized AF treatment through its tissue selectivity, safety, and procedural efficiency. Yet, early-generation systems using microsecond pulses face key challenges—excessive muscle stimulation, reliance on general anesthesia, and risks like hemolysis and gas embolism—that limit broad adoption.

As the world's first and only commercially available nanosecond PFA system, NxPFA™ represents the "Next of PFA" generation. It combines the MaviPulse™ high repetition frequency ns-PFA console with the InteShot™ basket-shaped catheter to deliver irreversible electroporation of cardiomyocytes via high-voltage nanosecond pulses, effectively overcoming key limitations of microsecond PFA (μs-PFA) technologies:

Significantly reduces neuromuscular stimulation, enabling procedures under conscious sedation, improving patient comfort and lowering anesthesia risks;

Combines nanosecond pulses with a basket-shaped catheter to ensure optimal electrode-tissue contact and high success rates, while shortening procedural time;

Substantially lowers intravascular gas formation, lowering the risk of stroke or systemic embolism;

Minimizes erythrocytic damage and post-procedural bilirubin elevation, reducing potential kidney injury.

NxPFA™ Demonstrates Outstanding Efficacy and Safety

The NxPFA™ system has been clinically validated through the SCENA-AF multicenter registration trial, which enrolled 166 patients with paroxysmal atrial fibrillation. The data has been acknowledged by NMPA and will soon be published in an academic journal. Key outcomes include:

100% acute pulmonary vein isolation success rate

88.27% one-year treatment success rate (PPS)

No device-related serious adverse events reported

Over 92.8% of procedures completed under conscious sedation, with excellent intraoperative tolerance.

These results confirm NxPFA™'s strong performance in efficacy, safety, efficiency, and patient comfort. It remains the only PFA system globally to achieve one-shot PVI under conscious sedation with high success, marking the debut of the third-generation nanosecond PFA era.

"NxPFA™'s approval is not only a major milestone for Pulsecare Medical but also a transformative breakthrough for cardiac electrophysiology. With NxPFA™, we address critical clinical challenges and look forward to collaborating with global EP experts to shape the future of arrhythmia treatment—delivering smarter tools to physicians and safer, more effective, more comfortable therapies to patients," said Dr. Javen Tan, CEO of Pulsecare Medical.

About PulseCare Medical

Founded in July 2021 and headquartered in Shenzhen, Pulsecare Medical is dedicated to the innovation and development of cardiovascular multimodal therapeutic devices. Backed by a rare cross-disciplinary team combining clinical and engineering expertise, the company is building a next-generation energy platform for interventional therapies. Pulsecare offers total solutions for cardiac electrophysiology and hypertension interventional therapy, aiming to lead in minimally and non-invasive treatments.

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